Lipid lowering with bempedoic acid added to a proprotein convertase subtilisin/kexin type 9 inhibitor therapy: A randomized, controlled trial
| Autor: | Narendra D. Lalwani, Diane E. MacDougall, John Rubino, Stephanie E. Kelly, Lulu Ren Sterling, James M. McKenney |
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| Rok vydání: | 2020 |
| Předmět: |
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medicine.medical_specialty Apolipoprotein B Endocrinology Diabetes and Metabolism Hypercholesterolemia 030204 cardiovascular system & hematology Placebo Gastroenterology law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Ezetimibe Double-Blind Method law Internal medicine Internal Medicine medicine Humans Dicarboxylic Acids 030212 general & internal medicine Aged Hypolipidemic Agents Nutrition and Dietetics biology business.industry C-reactive protein Fatty Acids PCSK9 Inhibitors Cholesterol LDL Middle Aged Discontinuation Evolocumab biology.protein Kexin lipids (amino acids peptides and proteins) Drug Therapy Combination Female Proprotein Convertase 9 Cardiology and Cardiovascular Medicine business medicine.drug |
| Zdroj: | Journal of clinical lipidology. 15(4) |
| ISSN: | 1933-2874 |
| Popis: | BACKGROUND Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9is) lower low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia. However, some patients receiving PCSK9i therapy might require additional lipid-lowering therapy (LLT) to reach LDL-C goals. Bempedoic acid is an oral, once-daily, ATP-citrate lyase inhibitor that significantly lowers LDL-C in patients with hypercholesterolemia when given alone or as add-on therapy to statins and/or ezetimibe. OBJECTIVE Assess safety and efficacy of bempedoic acid added to PCSK9i (evolocumab) background therapy in patients with hypercholesterolemia. METHODS This phase 2, randomized, double-blind, placebo-controlled study was conducted in three phases: 1.5-month screening/washout period including discontinuation of all LLTs, a 3-month period wherein patients initiated background PCSK9i therapy, and a 2-month treatment period in which patients were randomized 1:1 to receive bempedoic acid 180 mg or placebo once daily while continuing PCSK9i therapy. RESULTS Of 59 patients randomized, 57 completed the study. Mean baseline LDL-C after 3 months of PCSK9i background therapy was 103.1 ± ± 30.4 mg/dL. Bempedoic acid added to background PCSK9i therapy significantly lowered LDL-C by 30.3% (P < .001) vs placebo. Compared with placebo, bempedoic acid significantly lowered apolipoprotein B, non-high-density lipoprotein cholesterol, and total cholesterol (nominal P < .001 for all), and high-sensitivity C-reactive protein (P = .029). When added to background PCSK9i therapy, the safety profile of bempedoic acid was comparable to that observed for placebo. CONCLUSIONS When added to a background of PCSK9i therapy, bempedoic acid significantly lowered LDL-C levels with a safety profile comparable to placebo in patients with hypercholesterolemia. |
| Databáze: | OpenAIRE |
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